ALBENZA

Product NDC
64896-693
11-digit product format
648960693
Labeler code
64896
Product ID
64896-693_6163d9cc-fcc2-40a8-9b3d-0cce16b99b27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
albendazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
NDA020666
Marketing category
NDA
Marketing start
1996-06-11
Substance
ALBENDAZOLE
Active strength
200 mg/1
Pharmacologic classes
Anthelmintic [EPC], Cytochrome P450 1A Inducers [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ALBENZA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBENDAZOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF4216019LN
Rxcui199672, 211148

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b0e27303-91cd-2fd1-e9ec-fbe22a3c3f49Product name820250325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64896-693-49ALBENZA2 in 1 BOTTLETABLET, FILM COATED214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64896-693-49EA - Each64896-693daf7b7c1-fde0-4ddb-b723-52c00c8968a712020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64896-693ALBENZA (ALBENDAZOLE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC]14Current NDC, Legacy NDC, 1 package rows20241025_1977a867-0ee1-44c0-8da3-fe59c48699f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199672albendazole 200 MG Oral TabletPSN1977a867-0ee1-44c0-8da3-fe59c48699f514
211148Albenza 200 MG Oral TabletPSN1977a867-0ee1-44c0-8da3-fe59c48699f514
211148albendazole 200 MG Oral Tablet [Albenza]SBD1977a867-0ee1-44c0-8da3-fe59c48699f514
199672albendazole 200 MG Oral TabletSCD1977a867-0ee1-44c0-8da3-fe59c48699f514
211148Albenza 200 MG Oral TabletSY1977a867-0ee1-44c0-8da3-fe59c48699f514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64896-693-49648960693492 TABLET, FILM COATED in 1 BOTTLE (64896-693-49) 1996-06-110000-00-00NoNoCurrent